Duns Number:663190222
Device Description: Electrode Adapt Cable
Catalog Number
-
Brand Name
LCCS
Version/Model Number
IKD-S-30-LC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
e49b8353-7023-40f5-8206-0ebefaaa74a6
Public Version Date
August 02, 2021
Public Version Number
1
DI Record Publish Date
July 24, 2021
Package DI Number
14895233605633
Quantity per Package
15
Contains DI Package
04895233605636
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |